Association Between Smell Loss, Disease Burden, and Dupilumab Efficacy in Chronic Rhinosinusitis with Nasal Polyps.

IF 2.5 3区医学 Q1 OTORHINOLARYNGOLOGY American Journal of Rhinology & Allergy Pub Date : 2024-09-19 DOI:10.1177/19458924241274501

Zachary M Soler, Zara M Patel, Joaquim Mullol, Jose Mattos, Scott Nash, Changming Xia, Zhixiao Wang, Kinga Borsos, Mark Corbett, Juby A Jacob-Nara, Harry Sacks, Paul Rowe, Yamo Deniz, Andrew P Lane

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引用次数: 0

Abstract

Objective: To evaluate the association between smell loss and other aspects of disease, and evaluate dupilumab efficacy in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate or severe smell loss.

Methods: This post-hoc analysis of the SINUS-24/52 studies (NCT02912468/NCT02898454) analyzed nasal polyp score (NPS, 0-8), nasal congestion/obstruction (NC, 0-3), Lund-Mackay CT-scan score (LMK-CT, 0-24), rhinosinusitis severity visual analog scale (RS-VAS, 0-10), and 22-item Sinonasal Outcome Test (SNOT-22, 0-110) according to baseline monthly average patient-reported loss of smell scores (LoS, 0-3) of >1 to 2 (moderate) or >2 to 3 (severe) in patients randomized to dupilumab 300 mg or placebo every 2 weeks.

Results: Of 724 patients randomized, baseline LoS was severe in 601 (83%) and moderate in 106 (15%). At baseline, severe versus moderate LoS was associated with 1-point greater severity of NC (odds ratio [OR] 6.01 [95% confidence interval, (CI) 3.95, 9.15]), 5-point greater severity of LMK-CT (OR 2.19 [1.69, 2.85]), and 8.9-point greater severity of SNOT-22 (OR 1.35 [1.20, 1.49]). At Week 24, least squares mean differences (95% CI) dupilumab versus placebo in change from baseline were: NPS -1.90 (-2.56, -1.25) and -1.95 (-2.20, -1.70) in the moderate and severe baseline LoS subgroups, respectively; NC -.35 (-.64, -.06) and -1.00 (-1.13, -.87); LMK-CT -6.30 (-7.88, -4.72) and -6.22 (-6.82, -5.63); RS-VAS -1.18 (-2.20, -.16) and -3.47 (-3.90, -3.03); and SNOT-22 -7.52 (-14.55, -.48) and -21.72 (-24.63, -18.82); all nominal P < .05 versus placebo. Improvements with dupilumab in NC, RS-VAS, and SNOT-22 were statistically greater in patients with severe versus moderate baseline LoS.

Conclusion: Significant smell impairment in severe CRSwNP is associated with significant disease (NC, RS-VAS, LMK), health-related quality of life impairment (SNOT-22), asthma, and non-steroidal anti-inflammatory drug-exacerbated respiratory disease. Dupilumab significantly improved NPS, NC, LMK-CT, RS-VAS, and SNOT-22 in subjects with moderate and severe baseline smell loss.

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慢性鼻窦炎伴鼻息肉患者的嗅觉丧失、疾病负担与杜匹单抗疗效之间的关系

目的评估嗅觉减退与疾病其他方面的关联，并评估杜必鲁单抗对重度慢性鼻炎伴鼻息肉（CRSwNP）和中度或重度嗅觉减退患者的疗效：这项对 SINUS-24/52 研究（NCT02912468/NCT02898454）的事后分析分析了鼻息肉评分（NPS，0-8）、鼻塞/阻塞（NC，0-3）、Lund-Mackay CT 扫描评分（LMK-CT，0-24）、鼻炎严重程度视觉模拟量表（RS-VAS，0-10）、根据基线月平均患者报告嗅觉丧失评分（LoS，0-3）>1-2（中度）或>2-3（重度），对随机接受杜必鲁单抗 300 毫克或安慰剂治疗的患者进行 22 项鼻窦结果测试（SNOT-22，0-110）。研究结果在随机接受治疗的 724 名患者中，601 人（83%）的基线 LoS 为重度，106 人（15%）的基线 LoS 为中度。基线时，重度 LoS 与中度 LoS 相比，NC 的严重程度要高 1 点（比值比 [OR] 6.01 [95% 置信区间 (CI) 3.95, 9.15]），LMK-CT 的严重程度要高 5 点（比值比 2.19 [1.69, 2.85]），SNOT-22 的严重程度要高 8.9 点（比值比 1.35 [1.20, 1.49]）。第 24 周时，dupilumab 与安慰剂相比，与基线相比的最小二乘法平均差（95% CI）为中度和重度基线 LoS 亚组的 NPS 分别为 -1.90（-2.56，-1.25）和 -1.95（-2.20，-1.70）；NC 分别为 -.35 （-.64，-.06）和 -1.00（-1.13，-.87）；LMK-CT 分别为 -6.30（-7.88，-4.72）和-6.22（-6.82，-5.63）；RS-VAS-1.18（-2.20，-.16）和-3.47（-3.90，-3.03）；SNOT-22-7.52（-14.55，-.48）和-21.72（-24.63，-18.82）；均为名义 P 结论：严重 CRSwNP 患者明显的嗅觉障碍与严重疾病（NC、RS-VAS、LMK）、健康相关生活质量障碍（SNOT-22）、哮喘和非甾体抗炎药加重的呼吸系统疾病有关。杜比鲁单抗能明显改善中度和重度基线嗅觉丧失受试者的NPS、NC、LMK-CT、RS-VAS和SNOT-22。

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来源期刊

American Journal of Rhinology & Allergy 医学-耳鼻喉科学

CiteScore

5.60

自引率

11.50%

发文量

审稿时长

4-8 weeks

期刊介绍： The American Journal of Rhinology & Allergy is a peer-reviewed, scientific publication committed to expanding knowledge and publishing the best clinical and basic research within the fields of Rhinology & Allergy. Its focus is to publish information which contributes to improved quality of care for patients with nasal and sinus disorders. Its primary readership consists of otolaryngologists, allergists, and plastic surgeons. Published material includes peer-reviewed original research, clinical trials, and review articles.